eTMF Study Migrations: Planning with Inspection Readiness in Mind

September 25, 2017

Migration can be one of the most challenging aspects of implementing any new technology. Studies have shown that between 38%[1]and 50%[2] of all migration projects are late, over budget or failed. The most common reasons for failure were not based on technology issues but people issues.

In the world of eTMF, measuring migration success is more rigorous than for many other applications. Not only does the content need to be migrated to a new system, but it also must be suitable for inspection by a health authority. In this article, we’ll look at some key considerations for eTMF migration approaches that help to provide confidence that migrated TMFs are inspection-ready.

Do You Need to Migrate?

There are a number of circumstances which may drive a sponsor (or other organization) to migrate TMFs into an eTMF system:

Receipt of the TMF from a CRO at the end of a study

Transfer from another sponsor when a compound is acquired

Migration from an existing eTMF to a new eTMF

Digitizing of a paper TMF

In some cases, the cost associated with a migration may not be justified. For example, a five year old CRO-run study that was received electronically might just be archived security and not migrated to a new eTMF. Phase 1 paper studies might be left in paper form. In both cases, the unlikelihood of a GCP inspection and the availability of the file, even if not in optimal form, mitigate against the need to migrate. As in most areas, a risk-based approach is warranted.

Confidence in the Source Files

In your own eTMF, you should be taking a Quality by Design (QbD) approach by defining the key quality attributes of the system and then monitoring against those attributes. Typically, they will include completeness, quality and timeliness.

However, when you inherit a TMF, it’s too late for Quality by Design – you will have to rely on Quality by Inspection. The need for inspection will depend on the level of confidence you have in the source file. When you migrate your legacy eTMF, you no doubt have a high level of understanding of the processes used in, and the quality of, the file. At this point, further quality checks may not be productive. If you are accepting a CRO file where you were providing consistent oversight, the need to perform checks might be low. For a CRO file that has received little oversight, or an acquired TMF, a more thorough inspection may be called for – especially for pivotal trials or other TMFs that are likely to undergo a health authority inspection.

Quality Checks

Depending on what you know about the source data, you may need to do specified or sampled quality checks on the file. These could be done before or after the TMF is migrated into the target eTMF system.

eTMF completeness per plan. Do you have a TMF plan or index that specifies what should be in the file? How confident are you that all required documents are present?

Availability of critical documentation. Have you identified document types pose the highest risk to trial integrity or safety of subjects? Which will the inspector need to be able to reconstruct the study, including key decisions?

Document quality. Do you need to spot-check document content, or do you have a high level of confidence that content is complete and accurately file?Is it Easy?

The level of manual effort required for migration will depend on the quality of the source file (especially metadata), the amount of mapping needed between the source system and the target eTMF. Any claim that the process will be fast and easy, especially from a vendor, should be examined closely based on a definition of migration success which should include having confidence in the following:

All required documents are present

Documents have been properly classified

Documents have accurate metadata including name and date

Content is accurate and complete

Associated processes have been completed, such as archiving of any required paper

Taking a risk-based approach to migration strategy will focus resources where they are needed to ensure migration success and in turn assure that migrated eTMFs are inspection ready.